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RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas (RADCHOP)

Primary Purpose

Peripheral T Cell Lymphoma Unspecified, Anaplastic Large Cell Lymphoma, ALK-negative, Angioimmunoblastic T Cell Lymphoma

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
RAD001 (Everolimus)
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral T Cell Lymphoma Unspecified focused on measuring RAD001, chemotherpy, T cell lymphoma

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically proven peripheral T-cell lymphoma, unspecified, (PTCL), ALK-negative anaplastic large cell T-cell lymphoma (ALCL), Angioimmunoblastic T cell lymphoma (AITL), Cutaneous T-cell lymphoma

  2. Adequate organ function as defined by the following criteria:

    A.Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy B.Total serum bilirubin ≤1.5 x ULN C.Absolute neutrophil count (ANC) ≥1500/µL D.Platelets ≥100,000/µL E.Hemoglobin ≥9.0 g/dL (may be transfused or erythropoietin treated) F.Serum calcium ≤12.0 mg/dL G.Serum creatinine ≤1.5 x ULN

  3. At least one measurable lesion
  4. ECOG PS 0-2
  5. Informed consent
  6. Age 20 to 70 years old

Exclusion Criteria:

  1. Prior radiation therapy or surgery within 4 weeks prior to study entry
  2. History of central nervous system (CNS) metastases
  3. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2.
  4. Pregnancy or breastfeeding.
  5. Hepatitis B virus surface antigen positive
  6. Extranodal NK/T cell lymphoma
  7. Mycosis fungoides
  8. ALK-positive Anaplastic large cell lymphoma

Sites / Locations

  • National Cancer Center
  • Samsung Medical Center
  • Asan Medical Center
  • Korea Cancer Center Hospital
  • Yonsei Medical Center, Severance Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RAD001-CHOP

Arm Description

Prospective multicenter open-label phase I/II study Phase I: RAD001 2.5 - 10 mg PO daily D1-14 + CHOP every 3 weeks Phase II: Determined dosage of RAD001 + CHOP every 3 weeks Treatment will be continued until planned 6 cycles or disease progression

Outcomes

Primary Outcome Measures

determination of the maximum tolerable dose and evaluation of response rate

Secondary Outcome Measures

doe-limiting toxicity and pharmacogenomics
Phase I To evaluate the dose-limiting toxicity To evaluate the pharmacokinetics of RAD001 Pharmacogenomic profiling Phase II To estimate the time to progression To estimate overall survival Pharmacogenomic profiling

Full Information

First Posted
September 8, 2010
Last Updated
March 1, 2015
Sponsor
Samsung Medical Center
Collaborators
Asan Medical Center, Yonsei University, National Cancer Center, Korea, Korea Cancer Center Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01198665
Brief Title
RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas
Acronym
RADCHOP
Official Title
A Phase I/II Study of RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Asan Medical Center, Yonsei University, National Cancer Center, Korea, Korea Cancer Center Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The urgent need for new effective therapy for T-cell lymphoma patients and promising results observed so far in trials with RAD001(everolimus, mTOR inhibitor) strongly warrants the investigation of RAD001 combined with CHOP as a first-line treatment in peripheral T-cell lymphoma patients. Thus, we designed a phase I/II study with the combination of RAD001 with CHOP chemotherapy for newly diagnosed peripheral T-cell lymphoma patients. Phase I Primary objective : To define the maximum tolerable dose Secondary objective To evaluate the dose-limiting toxicity To evaluate the pharmacokinetics of RAD001 Pharmacogenomic profiling Phase II Primary objective : To evaluate the overall response rate Secondary objective To estimate the time to progression To estimate overall survival Pharmacogenomic profiling
Detailed Description
Phase I Level 1: RAD001 2.5 mg PO daily D1-14 + CHOP Level 2: RAD001 5 mg PO daily D1-14 + CHOP Level 3: RAD001 7.5 mg PO daily D1-14 + CHOP Level 4: RAD001 10 mg PO daily D1-14 + CHOP CHOP every 3 weeks D1 Cytoxan 750mg/m2 + D5W 100ml MIV over 1hr D1 Doxorubicin 50mg/m2 + D5W 100ml MIV over 30mins D1 Vincristine 1.4mg/m2 (max.2mg) IV push D1-D5 Prednisolone 100mg/d PO (40-30-30) Phase II Determined dosage of RAD001 + CHOP every 3 weeks Treatment will be continued until planned 6 cycles or disease progression

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T Cell Lymphoma Unspecified, Anaplastic Large Cell Lymphoma, ALK-negative, Angioimmunoblastic T Cell Lymphoma, Cutaneous T Cell Lymphoma
Keywords
RAD001, chemotherpy, T cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RAD001-CHOP
Arm Type
Experimental
Arm Description
Prospective multicenter open-label phase I/II study Phase I: RAD001 2.5 - 10 mg PO daily D1-14 + CHOP every 3 weeks Phase II: Determined dosage of RAD001 + CHOP every 3 weeks Treatment will be continued until planned 6 cycles or disease progression
Intervention Type
Drug
Intervention Name(s)
RAD001 (Everolimus)
Other Intervention Name(s)
Cytoxan, Doxorubicin, Vincristine, prednisolone
Intervention Description
Phase I Level 1: RAD001 2.5 mg PO daily D1-14 + CHOP Level 2: RAD001 5 mg PO daily D1-14 + CHOP Level 3: RAD001 7.5 mg PO daily D1-14 + CHOP Level 4: RAD001 10 mg PO daily D1-14 + CHOP CHOP every 3 weeks D1 Cytoxan 750mg/m2 + D5W 100ml MIV over 1hr D1 Doxorubicin 50mg/m2 + D5W 100ml MIV over 30mins D1 Vincristine 1.4mg/m2 (max.2mg) IV push D1-D5 Prednisolone 100mg/d PO (40-30-30) Phase II Determined dosage of RAD001 + CHOP every 3 weeks
Primary Outcome Measure Information:
Title
determination of the maximum tolerable dose and evaluation of response rate
Time Frame
Phase I for maximal tolerable dose and phase II for efficacy
Secondary Outcome Measure Information:
Title
doe-limiting toxicity and pharmacogenomics
Description
Phase I To evaluate the dose-limiting toxicity To evaluate the pharmacokinetics of RAD001 Pharmacogenomic profiling Phase II To estimate the time to progression To estimate overall survival Pharmacogenomic profiling
Time Frame
Phase I/II

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven peripheral T-cell lymphoma, unspecified, (PTCL), ALK-negative anaplastic large cell T-cell lymphoma (ALCL), Angioimmunoblastic T cell lymphoma (AITL), Cutaneous T-cell lymphoma Adequate organ function as defined by the following criteria: A.Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy B.Total serum bilirubin ≤1.5 x ULN C.Absolute neutrophil count (ANC) ≥1500/µL D.Platelets ≥100,000/µL E.Hemoglobin ≥9.0 g/dL (may be transfused or erythropoietin treated) F.Serum calcium ≤12.0 mg/dL G.Serum creatinine ≤1.5 x ULN At least one measurable lesion ECOG PS 0-2 Informed consent Age 20 to 70 years old Exclusion Criteria: Prior radiation therapy or surgery within 4 weeks prior to study entry History of central nervous system (CNS) metastases Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2. Pregnancy or breastfeeding. Hepatitis B virus surface antigen positive Extranodal NK/T cell lymphoma Mycosis fungoides ALK-positive Anaplastic large cell lymphoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Seog Kim, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Kyoungki-do
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135710
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea Cancer Center Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei Medical Center, Severance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas

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